Obstructive Sleep Apnea (OSA) is a very common chronic disease with many adverse clinical consequences, affecting an estimated 10-20% of population. The majority of these patients remain undiagnosed and the studies show the percentage of undiagnosed OSA could be as high as 80-90%. Untreated OSA is associated with higher risk of fatal cardiovascular and cerebrovascular event, hence, the importance of long-term treatment of the patients. Currently, the most common prescribed treatment for OSA patients is continuous positive airway pressure (CPAP) therapy. Although this treatment is very efficacious and relatively safe with minor side-effects, the patient compliance is low and many patients refuse to start treatment on CPAP. It is reported that the compliance could be as low as 50%, therefore an alternative therapy is required. Many patients prefer oral appliance therapy and compliance is reported to be higher than CPAP. There has been a tremendous growth in this area of dentistry over the past decade and many patients are now seeking this treatment modality.
The number of patients seeking oral appliance therapy will increase current clinical workflow models and device manufacturing may not be able to keep up with the increased demand. Therefore, having more efficient workflow systems and device manufacturing becomes crucial in delivery of care. Digital manufacturing of oral appliances is becoming increasingly popular, favored for the cost savings in manufacturing the device as well as the ability to make modifications easily to the patient's custom device. To date, the digitally manufactured devices are generally made from scans of physical models, poured from plaster and made from physical registration of the bite using a typical bite fork (e.g. a GEORGE GAUGE of Great Lakes Orthodontics, Ltd. of Tonawanda, N.Y. and/or as described in U.S. Pat. No. 5,154,609 to George). The use of a physical bite registration in the digital manufacture of devices creates inefficiencies in the workflow, and can also introduce inaccuracies in the device manufacturing as the difference in the degree of accuracy between conventional bite registration using Polyvinyl Siloxane (PVS) material and digital bite registration could result in improper articulation of the models.